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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheostomy (W/Wo Connector)
510(k) Number K030381
Device Name PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
Applicant
Portex , Ltd.
Military Rd.
Hythe, Kent
England Ct21 6db,  GB
Applicant Contact STEVE OGILVIE
Correspondent
Portex , Ltd.
Military Rd.
Hythe, Kent
England Ct21 6db,  GB
Correspondent Contact STEVE OGILVIE
Regulation Number868.5800
Classification Product Code
BTO  
Date Received02/05/2003
Decision Date 08/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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